Non-Invasive Biomarkers for NASH Clinical Research Studies
Posted: October 8, 2020
Biomarker Assays for
NASH Clinical Trials
Cytokeratin 18 (CK18 and ccK18):
Non-invasive biomarkers for assessing hepatocyte apoptosis and necrosis
|Biomarker||Utility in NASH Clinical Trials||Available Assays||Catalog #|
|Total CK18 (M65®)||Biomarker for hepatocyte cell death (apoptosis and necrosis)||M65® ELISA||P10020|
|M65® EpiDeath ELISA||P10040|
|Biomarker for hepatocyte apoptosis||M30® Apoptosense ELISA||P10011|
- In early phase NASH trials, performing liver biopsies to evaluate the effect of a potential drug candidate is not always practical or feasible.
- These relatively short-duration early trials may not result in significant changes in liver histology.
- Traditional non-invasive biomarkers for NASH, such as serum ALT and AST levels, are notoriously insensitive and non-specific, and do not always accurately reflect the extent of liver injury.
The Solution: Non-Invasive, mechanistic biomarkers that are reflective and predictive of changes in liver histology
- Serum CK18 (M65®) and ccK18 (M30®) measure hepatocyte apoptosis and necrosis.
- Apoptosis and necrosis are underlying mechanisms that are directly involved in the pathogenesis of NAFLD
- Changes in CK18 and ccK18 levels may therefore be early indicators for changes in disease activity in response to drug treatment.
- Changes in serum CK18 and ccK18 levels have been shown to correlate with histological changes in the liver.
Additional NASH Biomarker ELISAs from Diapharma
Use M30® Apoptosense® and M65® ELISA as part of your mechanistic biomarker panel to get a fuller picture of effects of your drug candidate.
Visit diapharma.com for our full portfolio of assays, including:
Collagen IV • L-FABP • FGF-19 • FGF-21 • Fibronectin • hsCRP • Mac-2-BP • Noggin • NGAL • Osteopontin • PAI-1 • sCD163
Research use only in the U.S. and Canada. Not for use in diagnostic procedures.
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